What’s new?
The cost of inspection and other MHRA fees are going up on 1 April 2023.
GDP Inspection fees will be increasing on 1 April 2023 to £2662 for a day's inspection and £1862 for a remote assessment.
Understanding the new GDP inspection model helps you factor what you will be charged when your inspection is due. Rather than several inspections every year I imagine it will typically now be between 5 and 8 days in a 6 month period, repeated every 3 or 4 years, depending on what deficiencies are found.
The risk based inspection approach has changed.
Previously the MHRA attempted to inspect all sites named on Wholesale Dealers Licences as required by the Compilation of Union Procedures on Inspections and Exchange of Information revision 18 that states:
Inspections should be carried out repeatedly to ensure compliance with GDP by the wholesale
distributor and the authorised premises. The intervals between inspections should be set at a level that provides confidence that the wholesale distributor maintains continued compliance with GDP and its principles. The maximum period between inspections per site should not exceed 5 years as lack of continuity may give rise to lower awareness of current GDP or allow significant deficiencies to develop.
You will know that some sites are infrequently inspected from the amount of expired GDP certificates on https://cms.mhra.gov.uk/mhra . The 3000 plus sites compared to the number of inspectors makes inspections of every site in 5 years unachievable.
Leaving the EU means the MHRA can try this new approach to manage GDP inspections.
What is the new GDP licence based Inspection programme for Wholesalers with multiple sites named on their licence?
At the GDP symposium it was announced the change to the risk based inspection programme for multi-site wholesalers.
The new model is intended to take a holistic approach to look at GDP compliance of the whole distribution operation. This will be done by one Inspector in a short period of time, rather than via individual site inspections conducted across a number of years by many different Inspectors.
The inspection focus is initially on the Head Office quality functions and how the Responsible Person manages GDP compliance across all the sites named on the WDA. There are then check inspections at short notice or unannounced at a sample of sites to examine if what was presented at the initial inspection is truly representative across the operation.
One rationale behind this is that one Inspector being responsible for a company and sampling evidence of compliance across various sites provides a better level of oversight than the old model.
So how will an inspection be conducted?
My understanding is a GDP Inspector will be allocated a company to inspect. If it has multiple sites they will arrange an inspection at what is identified as the Head Office or a site where most functions relating to the QMS are managed. This inspection will probably be over several days, possibly with some remote assessment and look at central functions like supplier and customer qualification and will test the QMS and how it applies to the operation. Looking at self inspections and KPIs from the various sites it will be used to decide how many of the sites on the licence should be inspected to provide assurance of GDP compliance. Previous inspection history of the company will also be a factor in the number of sites selected.
This initial inspection will then be followed up by short notice or unannounced inspections at a number of sites to test that what was presented at the Head Office is what occurs in practice.
How do we prepare for this new inspection?
The new element for the RP is the need to be able to demonstrate that all sites under their oversight are complying with SOPs and Quality policies. Some indicators I can imagine that would be examined at inspection are comparing deviations, CAPAs, complaints and returns to saleable stock from the different sites.
These are all useful markers to see if sites are broadly in alignment with each other. A site with few deviations compared to others would be the one I would pick to audit. The schedules and outcomes from self inspections will also be key documents. Sites doing atypical activities such as export or import from approved countries may also be considered higher risk and need a site inspection.
Short notice and unannounced inspections are challenging for any organisation. The importance of training key staff at each site on how to host an inspection potentially without RP support needs to be considered.
Companies are expected to be inspection ready at any point and this new model will test this to an extent not previously seen. Companies that aren’t prepared and are unable to demonstrate GDP compliance can expect more inspection oversight with the corresponding increase in inspection fees.
To be prepared for your next inspection, having external audits can greatly assist in providing an independent objective assessment of the state of compliance.
My contact details are below!
Full disclosure: the concepts of this plan were from when I was the GDP Expert Inspector. I proposed some of these changes to the inspection programme and do believe that if implemented effectively it will benefit both patients and companies compared to the previous model.
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